четверг, 9 июня 2011 г.

Enrollment In Amoxicillin PULSYS Phase III Trial Completed

Advancis
Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today
announced that it has completed enrollment in the Company's Amoxicillin
PULSYS Phase III clinical trial for the treatment of
pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis
concluded enrollment with a total of 620 adult/adolescent patients as of
close-of-business May 31, 2006.


Advancis' adult and adolescent pivotal program is designed as a 600-
patient, double-blind, double-dummy, non-inferiority Phase III trial and
began on November 9, 2005. Over the coming weeks, patients will complete
their treatment and follow-up visits, and Advancis and its clinical
research organization will collect and analyze the clinical data. The
Company expects to publicly report top-line results around mid-August 2006.
If the trial is successful, Advancis expects to file a 505(b)(2) New Drug
Application (NDA) with the U.S. Food and Drug Administration for the
product early in the first quarter of 2007.


"We are very pleased to have completed enrollment in our adult and
adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D.,
Advancis president and CEO. "We are hopeful that, if successful,
Amoxicillin PULSYS will provide physicians a tool to deliver the
established safety and efficacy of amoxicillin in the first and only
once-daily presentation in the U.S."


Advancis is comparing its Amoxicillin PULSYS dosage form for the
treatment of pharyngitis/tonsillitis in adults delivered in a once-daily,
775 milligram tablet for a period of 10 days to 250 milligrams of
penicillin dosed four times daily, for a total of one gram per day, for 10
days. The primary endpoint for the study is bacterial eradication, as
measured by throat cultures obtained both before and after treatment.


More than 59 million prescriptions for amoxicillin were written in 2005
with total retail sales of approximately $640 million. Amoxicillin is
indicated for a broad range of infections, and is commonly prescribed as a
first-line therapy for common infections such as otitis media (middle ear
infection), pharyngitis (sore throat), and sinusitis (sinus infection).
According to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.



ABOUT ADVANCIS PHARMACEUTICAL:


Advancis Pharmaceutical Corporation (Nasdaq: AVNC) is a pharmaceutical
company focused on the development and commercialization of anti-infective
drug products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing a portfolio of
anti-infective drugs based on its novel biological finding that bacteria
exposed to antibiotics in frontloaded staccato bursts, or "pulses," are
killed more efficiently and effectively than those under standard treatment
regimens. Based on this finding, Advancis has developed a proprietary,
once-a-day pulsatile delivery technology called PULSYS. By examining the
resistance patterns of bacteria and applying its delivery technologies,
Advancis has the potential to redefine infectious disease therapy and
significantly improve drug efficacy, shorten length of therapy, and reduce
drug resistance versus currently available antibacterial products. For more
on Advancis, please visit advancispharm.















This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements are based on Advancis' current expectations and assumptions.
These statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual results to
differ materially from those anticipated. The words, "believe," "expect,"
"intend," "anticipate," "plan," "hope," and variations of such words, and
similar expressions identify forward-looking statements, but their absence
does not mean that the statement is not forward-looking. Statements in this
announcement that are forward- looking include, but are not limited to,
statements about the Company's future development plans, clinical trials,
and financial results. The actual results realized by Advancis could differ
materially from these forward-looking statements, depending in particular
upon the risks and uncertainties described in the Company's filings with
the Securities and Exchange Commission. These include, without limitation,
risks and uncertainties relating to the Company's financial results and the
ability of the Company to (1) reach profitability, (2) prove that the
preliminary findings for its product candidates are valid, (3) receive
required regulatory approvals, (4) successfully conduct clinical trials in
a timely manner, (5) establish its competitive position for its products,
(6) develop and commercialize products that are superior to existing or
newly developed competitor products, (7) develop products without any
defects, (8) have sufficient capital resources to fund its operations, (9)
protect its intellectual property rights and patents, (10) implement its
sales and marketing strategy, (11) successfully attract and retain
collaborative partners, (12) successfully develop, receive regulatory
approval, and commercialize any new Keflex products, and (13) retain its
senior management and other personnel. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis undertakes no
obligation to update or revise the information in this announcement,
whether as a result of new information, future events or circumstances or
otherwise.


Advancis Pharmaceutical Corporation

advancispharm/

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